510(k) Regulatory Affairs Specialist
Job Description
- Author 510(k) submissions in the US FDA electronic system for Class I Medical Devices.
- Review and approve promotional materials and labeling for impact to product classification and 510(k)’s.
- Under supervision - Coordinate, compile, and submit regulatory applications to competent authorities, notified bodies, regulatory agencies, and international business partners, including the preparation of key market international documents, including technical files and 510(k)’s.
- Work with the Director of Regulatory Affairs to ensure rapid and timely approval of new and continued regulatory support of products marketed within and outside the United States, including labeling guidance and adequate deliverables required for technical file and US FDA requirements.
- Evaluate proposed product modifications for domestic and international regulatory impact, completing regulatory assessments as needed in change control process.
- Ensure compliance with applicable US and international regulations and standards.
- Oversee MDR and complaints; submit adverse events to the US FDA and assess impact to other markets.
- Ensure preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Additional related duties.
- Bachelor's Degree in Science or a Medical / Healthcare related field preferred.
- Must have experience authoring 510(k) submissions in the US FDA electronic system.
- Regulatory and/or Quality experience with US-regulated Class I Medical Devices.
- Working knowledge of Regulatory Authority computerized submission systems in ESG portal.
- Excellent written and verbal communication skills.
- Must reside within a commutable distance from Schaumburg, IL and be available to work onsite daily.
Meet Your Recruiter
Mike Schmitz
Technical Recruiter
Mike Schmitz is an esteemed Recruiting Team Leader specializing in the Life Sciences Division. With an impressive tenure of over 12 years at Sterling and a remarkable 16-year career in the recruiting arena, Mike has cemented his reputation as a trailblazer in talent acquisition.
As a Recruiting Team Leader, Mike's understanding of the intricacies within the Life Sciences Division is unparalleled. His expertise positions him as a strategic partner in bridging the gap between talented professionals and opportunities that align with their aspirations.
With a career spanning 16 years, Mike's journey in the recruitment landscape has been defined by his dedication to facilitating more fulfilling careers for skilled professionals. His ability to understand everyone’s unique strengths and match them with roles that foster growth and satisfaction marks him as a true advocate for professional development.
Mike's advice to candidates reflects his commitment to helping them excel: approach every job interview with positivity and authenticity. He firmly believes that a positive attitude and an engaging personality are pivotal in creating lasting impressions. Mike emphasizes that while technical qualifications are crucial, the ability to connect with interviewers and present oneself effectively is equally valuable to prospective employers.